Devices and methods for creating wedge-shaped recesses

ABSTRACT

A method of creating a wedge-shaped recess in a bone is disclosed. The method includes creating a cylindrical recess within a bone, positioning a tool within the cylindrical recess, radially expanding an articulating cutter of the tool and rotating the tool to remove additional bone along the cylindrical recess&#39; side walls and create a wedge-shaped recess; wherein, a diameter of the bottom surface of the wedge-shaped recess is larger than a diameter of a surface opening of the wedge-shaped recess.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 15/386,756 which is a continuation application of U.S. patentapplication Ser. No. 14/826,918, filed Aug. 14, 2015, now U.S. Pat. No.9,526,632, which is a continuation application of U.S. patentapplication Ser. No. 13/480,272, filed May 24, 2012, now a U.S. Pat. No.9,155,543, which claims priority benefit of U.S. Provisional ApplicationNo. 61/490,507, filed May 26, 2011, the entireties of all of which arehereby incorporated by reference herein.

BACKGROUND Field

This application relates generally to anatomical implants, and morespecifically, to hydrogel joint implants and various tools, devices,systems and methods related thereto.

Description of the Related Art

Implants are often used to replace deteriorated or otherwise damagedcartilage within a joint. Such devices can be used to treatosteoarthritis, rheumatoid arthritis, other inflammatory diseases,generalized joint pain and/or other joint diseases. To ensure properfunction and long term effectiveness, such implants should be properlysecured within a patient's bone or other implant site.

SUMMARY

According to some embodiments, a method of treating a joint of a patientcomprising creating a recess, hole or other opening in a bone located ator near a targeted joint, wherein the recess comprises a generallywedge, reverse tapered, truncated cone shape and/or other shape in whichthe bottom of the recess comprises a larger diameter or othercross-sectional dimension than a top of the recess. In some embodiments,the recess or other opening in the bone comprises a surface openingalong an outer surface of the bone, a bottom opening along the distalend of the recess and side walls that generally extend between thesurface opening and the bottom opening, wherein a diameter or othercross-sectional dimension of the bottom opening is larger than adiameter or other cross-sectional dimension of the surface opening.

According to some embodiments, the method further comprises at leastpartially radially compressing a joint implant having wedge or truncatedcone shape, wherein the joint implant comprises a first end and a secondend and a body extending between the first end and the second end. Insome embodiments, the second end of the implant is generally opposite ofthe implant's first end. In one embodiment, when the joint implant is ina radially uncompressed state, a diameter or other cross-sectionaldimension of the first end is smaller than a diameter or othercross-sectional dimension of the second end. The method furthercomprises inserting the joint implant within the recess, while the jointimplant is in a radially compressed state, wherein the second end of thejoint implant is inserted first within the recess. In some embodiments,the second end of the joint implant is adjacent the bottom opening ofthe recess, and the first end of the joint implant is adjacent thesurface opening of the recess when the joint implant is properlypositioned within the recess. The method further comprises, in someembodiments, releasing the joint implant from a radially compressedstate to a less compressed state, when the joint implant is properlypositioned within the recess, wherein, when the joint implant is in aless compressed state, the diameter or other cross-sectional dimensionof the second end of the joint implant is larger than the diameter orother cross-sectional dimension of the surface opening of the recess. Insome embodiments, when the joint implant is in a radially uncompressedstate, the body of the joint implant imparts a radial force at leastpartially along the side walls of the recess, thereby securing the jointimplant within the recess.

According to some embodiments, creating the recess in a bone comprisesusing a drill bit comprising an articulating cutter configured toselectively enlarge the recess near the bottom opening along the distalend of the recess. In some embodiments, creating the recess comprisesmoving a sleeve of the drill bit so as to radially expand thearticulating cutter outwardly at or near the distal end of the recess.In one embodiment, the drill bit is cannulated, wherein the drill bit ispositioned over a guide pin to place a working end of the drill bit neara targeted location of the recess.

According to some embodiments, the joint implant is radially compressedand inserted within the recess using an introducer. In some embodiments,the joint implant is urged through an interior of the introducer using aplunger or other pusher member. In some embodiments, the joint implantis urged through an interior of the introducer using amechanically-assisted device. In some embodiments, themechanically-assisted device comprises a handle and a clamp coupled tothe handle, wherein moving the clamp relative to the handle urges aplunger within an introducer to radially compress the joint implant andinsert the joint implant within the recess. In some embodiments, theclamp is rotatably coupled to the handle. In some embodiments, aninterior of the introducer is polished to further reduce friction. Insome embodiments, movement of the implant through an introducer isfacilitated with the use of a vacuum source, a pressure source and/orany other pneumatic, mechanical, electrical and/or other device.

According to some embodiments, the joint implant comprises a hydrogel,such as, for example, polyvinyl alcohol (PVA), other polymeric materialsand/or the like. In some embodiments, a content of PVA and/or any otherpolymeric component of the hydrogel is approximately 20% to 60% byweight (e.g., about 20, 25, 30, 35, 40, 45, 50, 55, 60%, values betweenthe foregoing percentages, etc.). In some embodiments, a content of PVAand/or any other polymeric component of the hydrogel is less thanapproximately 20% or greater than approximately 60% by weight. In someembodiments, a ratio of the diameter or other cross-sectional dimensionof the second end of the joint implant to the diameter or othercross-sectional dimension of the first end of the joint implant isapproximately between approximately 1.05 and 1.3 (e.g., about 1.05, 1.1,1.15, 1.2. 1.25, 1.3, ratios between the foregoing, etc.). In otherembodiments, a ratio of the diameter or other cross-sectional dimensionof the second end of the joint implant to the diameter or othercross-sectional dimension of the first end of the joint implant is lessthan approximately 1.05 or greater than approximately 1.3. In someembodiments, a ratio of the diameter or other cross-sectional dimensionof the second end of the joint implant to the diameter or othercross-sectional dimension of the first end of the joint implant is atleast about 1.1

According to some embodiments, the diameter or other cross-sectionaldimension of the second end of the implant is approximately 5% to 25%larger (e.g., about 5, 10, 15, 20, 25%, values between the foregoingpercentages, etc.) than the diameter or other cross-sectional dimensionof the implant. In some embodiments, the diameter or othercross-sectional dimension of the second end of the implant is less thanapproximately 5% or greater than approximately 25% of the diameter orother cross-sectional dimension of the implant. In some embodiments, therecess is located within or near at least one of a toe, finger, ankle,knee, shoulder, hip or any other joint. In some embodiments, the top endof the joint implant is approximately 5 mm to 20 mm (e.g., about 5, 6,7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm, values betweenthe foregoing, etc.) in diameter or in other cross-sectional dimension.In some embodiments, the top end of the joint implant is greater thanapproximately 20 mm or smaller than approximately 5 mm (e.g., about 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.9 mm, ranges between the foregoing, lessthan about 1 mm, etc.).

According to some embodiments, an implant configured for implantationwithin a joint of a patient comprises a top end configured to form anarticulation surface when properly implanted within a joint, a bottomend generally opposite of the top end and a main hydrogel body extendingbetween the top end and the bottom end and having a longitudinalcenterline. In some embodiments, such an implant comprises a hydrogel(e.g., PVA) implant or any other type of substrate-based implant. Insome embodiments, such an implant can be used in any of the jointtreatment methods disclosed herein. In some embodiments, a diameter or across-sectional dimension of the bottom end is greater than a diameteror a cross-sectional dimension of the top end. In one embodiment, sidewalls generally extend between the top end and the bottom end of theimplant, wherein the side walls are generally sloped relative to thelongitudinal centerline. In some embodiments, the implant comprises atapered shape due to, at least in part, to a difference between thediameters or cross-sectional dimensions of the top end and the bottomend. In some embodiments, the implant is configured for placement withinan implant site having a similar reverse tapered shape, thereby reducingthe likelihood of unintentional removal of the implant from the implantsite following implantation.

According to some embodiments, the hydrogel comprises polyvinyl alcohol(PVA) and/or any other polymeric material. In some embodiments, thecontent of PVA in the hydrogel is approximately 35% to 45% by weight(e.g., about 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45%, values betweenthe foregoing, etc.). In other embodiments, the content of PVA in thehydrogel is greater than approximately 45% by weight (e.g., about 45,50, 55, 60, 65, 70%, greater than about 70%, ranges between theforegoing values, etc.) or less than approximately 35% by weight (e.g.,5, 10, 15, 20, 25, 30, 35%, ranges between the foregoing values, lessthan about 5%, etc.). According to one embodiment, the content of PVA orother component in the hydrogel is approximately 40% by weight. In someembodiments, the implant is load bearing and generallynon-biodegradable. In some embodiments, the implant is configured forplacement within at least one of a toe, finger, ankle, knee, shoulder,hip or any other joint. In some embodiments, a transition between thetop end and the side walls is generally curved or otherwise smooth.

According to some embodiments, the top end of the implant isapproximately 5 mm to 20 mm in diameter or other cross-section dimension(e.g., about 5, 10, 15, 20 mm, ranges between the foregoing values,etc.). In other embodiments, the top end of the implant is greater thanabout 20 mm (e.g., 25, 30, 35, 40 mm, greater than 40 mm, etc.) orsmaller than about 5 mm (e.g., 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5 mm, rangesbetween the foregoing, less than about 1 mm, etc.). In some embodiments,a diameter of the bottom end is approximately 5% to 25% larger than adiameter of the top end (e.g., about 5, 6, 7, 8, 9, 10, 12, 14, 16, 18,20, 25%, ranges between the foregoing, less than about 5%, greater thanabout 25%, etc.). In some embodiments, a diameter of the bottom end isapproximately 10% to 15% larger than a diameter of the top end (e.g.,about 10, 11, 12, 13, 14, 15%, ranges between the foregoing, less thanabout 10%, greater than about 15%, etc.).

According to some embodiments, a distance between the top end and thebottom end of the implant is approximately 4 mm to 16 mm (e.g., about 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 mm, values between theforegoing, etc.). In other embodiments, a distance between the top endand the bottom end of the implant is less than approximately 4 mm (e.g.,less than 1 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, rangesbetween the foregoing, etc.) or greater than approximately 16 mm (e.g.,about 16, 17, 18, 19, 20, 22, 24, 26, 28, 30, 35, 40, 45, 50 mm, greaterthan about 50 mm, etc.). In some embodiments, a ratio of the diameter orother cross-sectional dimension of the bottom end of the implant to thediameter or other cross-sectional dimension of the top end of theimplant is approximately between 1.05 and 1.3 (e.g., about 1, 1.05, 1.1,1.15, 1.2, 1.25, 1.3, ranges between the foregoing, etc.). In someembodiments, a ratio of the diameter or other cross-sectional dimensionof the bottom end of the implant to the diameter or othercross-sectional dimension of the top end of the implant is greater thanabout 1.3 (e.g., about 1.3, 1.35, 1.4, 1.45, 1.5, 1.6, 1.7, 1.8, 1.9,2.0, greater than about 2.0, ranges between the foregoing, etc.). Insome embodiments, a ratio of the diameter or other cross-sectionaldimension of the bottom end of the implant to the diameter or othercross-sectional dimension of the top end of the implant is at leastabout 1.1.

According to some embodiments, a drill bit configured to be used with abone drill to make a reverse taper recess within a bone along or near ajoint of a patient comprises a main body comprising a proximal end and adistal end. Such a drill bit or other tool can be used in the method oftreating a joint and/or prior to delivering a reverse tapered implantinto the anatomy, in accordance with the disclosure provided herein. Insome embodiments, the proximal end of the main body is configured tocouple to a driving portion of a bone drill in order to selectivelyrotate said drill bit. In some embodiments, the drill bit or other toolcomprises a flange located along the distal end of the main body and oneor more (e.g., two, three, four, more than four) stationary cuttersextending distally from the flange, wherein the one or more stationarycutters are configured to create a generally cylindrical opening withina bone. In some embodiments, the drill bit or other tool furthercomprises at least one articulating cutter extending distally from theflange, wherein the articulating cutter is configured to be selectivelymoved between a stowed position and a radially extended position, andwherein the articulating cutter is configured to create a reverse taper,wedge, truncated cone or similarly shaped recess within a bone when inthe radially extended position, wherein a diameter or othercross-sectional dimension of a bottom opening of the recess is largerthan a diameter or other cross-sectional dimension of a surface openingof the recess.

According to some embodiments, wherein the drill bit comprising at leastone articulating cutter is inserted within a generally cylindricalrecess created by a first bit, wherein a reverse taper or similarlyshaped recess is created within the generally cylindrical recess whenthe at least one articulating cutter is moved (e.g., extended) to theradially extended position. According to some embodiments, the one ormore articulating cutters of the drill bit are coupled to the main bodyusing a hinge or other pivot point. In one embodiment, the articulatingcutter is normally resiliently biased in the stowed position. In otherembodiments, the articulating cutter is normally resiliently biased inthe expanded or extended position. In some embodiments, the drill bit iscannulated or otherwise comprises one or more openings or passages,thereby allowing the drill bit to be placed over a guide pin in order toaccurately position the drill bit to a targeted portion of a bone. Insome embodiments, the drill bit comprises a sleeve, sheath and/or otherouter member configured to be moved relative to the main body, whereinretracting the sleeve radially causes the at least one articulatingcutter to be moved from the stowed position and the radially extendedposition.

According to some embodiments, a mechanically-assisted delivery tool fordelivering an implant within a corresponding implant site comprises anintroducer tube comprising an inner lumen and a neck portion along adistal end of said introducer tube, wherein the inner lumen of theintroducer tube comprises a generally cylindrical portion along aproximal end of the introducer tube and a narrowed portion along thedistal end. In some embodiments, the neck portion of the introducer tubeis configured to be inserted within a recess or other opening createdwithin an implant site of a patient. In one embodiment, the introducertube comprises at least one slit or other recess or opening extending atleast partially along a length of the introducer tube. In someembodiments, the mechanically-assisted delivery tool comprises a plungeror other movable member configured to be at least partially insertedinto and moved within the lumen of the introducer tube. In someembodiments, the tool additionally comprises a handle coupled to theintroducer tube, wherein the handle comprises at least one opening. Insome embodiments, the tool comprises a clamp comprising a protrudingmember configured to be inserted within the at least one opening of thehandle to couple the clamp to the handle.

According to some embodiments, the clamp is rotatably movable relativeto the handle by movement of the protruding member within the at leastone opening. In some embodiments, the clamp is configured to beselectively moved within the at least one slit or other opening of theintroducer tube when the clamp is rotated relative to the handle.According to some embodiments, movement of the clamp within the at leastone slit toward the distal end of the introducer tube urges the plungerpositioned within the inner lumen of the introducer tube to move animplant placed within the lumen of the introducer tube to move withinthe narrowed portion of the inner lumen, through the neck portion of theintroducer tube and within a target implant site. In some embodiments,movement of the implant within the narrowed portion of the inner lumenradially compresses the implant.

According to some embodiments, the introducer tube, the handle, theclamp and the plunger are configured to be selectively separated fromone another to facilitate sterilization, cleaning, repairs, maintenanceand/or any other activity relating to the delivery tool. In someembodiments, the introducer tube is coupled to the handle using athreaded connection, a snap-fit connection, a pressure or friction fitconnection, a tab, other coupling and/or any other attachment device,system or method. In some embodiments, the narrowed portion of the innerlumen of the introducer tube comprises a generally linear slope. In someembodiments, the narrowed portion of the inner lumen of the introducertube comprises a generally non-linear (e.g., curved, undulating,rounded, etc.) shape or slope. In some embodiments, the narrowed portionof the inner lumen extends from the generally cylindrical portion to theneck portion of the introducer tube. In some embodiments, a head portionof the plunger comprises a motion limiter to limit movement of theplunger within the inner lumen of the introducer tube to a maximumdepth. In one embodiment, a proximal end of the introducer tubecomprises a flange or other flared portion.

According to some embodiments, a method of treating a joint of a patientcomprises creating a recess in a bone located at or near a targetedjoint, wherein the recess comprises a generally wedge, truncated cone orreverse tapered shape. In some embodiments, the recess in a bonecomprises a surface opening along an outer surface of the bone, a bottomopening along the distal end of the recess and side walls generallyextending between the surface opening and the bottom opening, wherein adiameter or other cross-sectional dimension of the bottom opening islarger than a diameter or other cross-sectional dimension of the surfaceopening. In one embodiment, the method comprises at least partiallyradially compressing a joint implant having wedge or truncated coneshape, wherein the joint implant includes a first end and a second endand body extending between the first end and the second end such thatthe second end is generally opposite of the first end. In someembodiments, when the joint implant is in a radially uncompressed state,a diameter or other cross-sectional dimension of the first end issmaller than a diameter or other cross-sectional dimension of the secondend. In some embodiments, while the joint implant is in a radiallycompressed state, the method additionally comprises inserting the jointimplant within the recess, wherein the second end of the joint implantis inserted first within the recess. In one embodiment, the second endof the joint implant is adjacent the bottom opening of the recess, andwherein the first end of the joint implant is adjacent the surfaceopening of the recess when the joint implant is properly positionedwithin the recess. In one embodiment, the method comprises releasing thejoint implant from a radially compressed state to a less compressedstate, when the joint implant is properly positioned within the recess.In one embodiment, when the joint implant is in a less compressed state,the diameter or other cross-sectional dimension of the second end of thejoint implant is larger than the diameter or other cross-sectionaldimension of the surface opening of the recess. In some embodiments,when the joint implant is in a radially uncompressed state, the body ofthe joint implant imparts a radial force at least partially along theside walls of the recess, thereby securing the joint implant within therecess.

According to some embodiments, creating the recess in a bone comprisesusing a drill bit comprising an articulating cutter configured toselectively enlarge the recess near the bottom opening along the distalend of the recess. In one embodiment, creating the recess comprisesmoving a sleeve of the drill bit so as to radially expand thearticulating cutter outwardly at or near the distal end of the recess.In some embodiments, the drill bit is cannulated. In one embodiment, thedrill bit is positioned over a guide pin or other guide or positioningmember to place a working end of the drill bit at or near a targetedlocation of the recess. In some embodiments, the joint implant isradially compressed and inserted within the recess using an introducer.In some embodiments, the joint implant is urged through an interior ofthe introducer using a plunger or other pusher member. In oneembodiment, the joint implant comprises a hydrogel. In some embodiments,the hydrogel comprises polyvinyl alcohol (PVA). In one embodiment, acontent of PVA and/or other component of the hydrogel is approximately20% to 60% by weight. In some embodiments, the water content of thehydrogel is approximately 40% to 80% by weight.

According to some embodiments, a ratio of the diameter or othercross-sectional dimension of the second end of the joint implant to thediameter or other cross-sectional dimension of the first end of thejoint implant is approximately between 1.05 and 1.3. In someembodiments, a ratio of the diameter or other cross-sectional dimensionof the second end of the joint implant to the diameter or othercross-sectional dimension of the first end of the joint implant is atleast about 1.1. In one embodiment, the diameter or othercross-sectional dimension of the second end of the implant isapproximately 5% to 25% larger than the diameter or othercross-sectional dimension of the implant. In some embodiments, therecess is located within or near at least one of a toe, finger, ankle,knee, shoulder, hip or other joint. In some embodiments, the top end ofthe joint implant is approximately 5 mm to 20 mm in diameter.

According to some embodiments, a drill bit configured to be used with abone drill to make a reverse taper or wedge recess within a bone alongor near a joint of a patient comprises a main body comprising a proximalend and a distal end, such that the proximal end of the main body isconfigured to couple to a driving portion of a bone drill in order toselectively rotate said drill bit. According to one embodiment, thedrill bit further comprises a flange located along the distal end of themain body. In some embodiments, the drill bit comprises one or morestationary cutters extending distally from the flange, wherein thestationary cutters are configured to create a generally cylindricalopening within a bone. The drill bit further comprises at least onearticulating cutter extending distally from the flange, wherein thearticulating cutter is configured to be selectively moved between astowed position and a radially extended position. In one embodiment, thearticulating cutter is configured to create a reverse taper or wedgeshaped recess within a bone when in the radially extended position,wherein a diameter of a bottom opening of the recess is larger than adiameter of a surface opening of the recess.

According to some embodiments, the drill bit comprising an articulatingcutter is inserted within a generally cylindrical recess created by afirst bit, such that a reverse taper recess or wedge shape is createdwithin the generally cylindrical recess when the articulating cutter ismoved to the radially extended position. In some embodiments, thearticulating cutter is coupled to the main body using a hinge or otherpivot point. In one embodiment, the at least one articulating cutter isnormally resiliently biased in the stowed position. In some embodiments,the drill bit is cannulated, allowing the drill bit to be placed over aguide pin or other positioning member in order to accurately positionthe drill bit to or near a targeted portion of a bone (e.g., joint). Inone embodiment, the drill bit further comprises a sleeve or othermovable member configured to be slid or otherwise moved relative to themain body, wherein retracting the sleeve or other member radially causesthe articulating cutter to be moved from the stowed position and theradially extended position.

According to some embodiments, a hydrogel implant configured forimplantation within a joint of a patient comprises a top end configuredto form an articulation surface when properly implanted within a joint,a bottom end generally opposite of the top end and a main hydrogel bodyextending between the top end and the bottom end and having alongitudinal centerline. In some embodiments, a diameter of the bottomend is greater than a diameter of the top end and side walls generallyextend between the top end and the bottom end, such that the side wallsare generally sloped relative to the longitudinal centerline. In oneembodiment, the implant comprises a tapered shape due to, at least inpart, to a difference between the diameters of the top end and thebottom end. In some embodiments, the implant is configured for placementwithin an implant site having a similar reverse tapered or wedge shape,thereby reducing the likelihood of unintentional removal of the implantfrom the implant site following implantation.

According to some embodiments, the hydrogel comprises polyvinyl alcohol(PVA) and/or another substance or additive. In some embodiments, thecontent of PVA and/or other substances is approximately 10% to 80%(e.g., about 35% to 45%) by weight. In some embodiments, the content ofPVA is approximately 40% by weight. In one embodiment, the content ofwater and/or saline in the hydrogel is 60% by weight. In one embodiment,the implant is load bearing and generally non-biodegradable. In someembodiments, the implant is configured for placement within at least oneof a toe, finger, ankle, knee, shoulder, hip or other joint. In someembodiments, a transition between the top end and the side walls isgenerally curved or otherwise smooth. In one embodiment, the top end ofthe implant is approximately 5 mm to 20 mm in diameter. In someembodiments, a diameter of the bottom end is approximately 5% to 25%larger than a diameter of the top end. In one embodiment, a diameter ofthe bottom end is approximately 10% to 15% larger than a diameter of thetop end. In some embodiments, a distance between the top end and thebottom end of the implant is approximately 4 mm to 16 mm. In oneembodiment, a ratio of the diameter or other cross-sectional dimensionof the bottom end of the implant to the diameter or othercross-sectional dimension of the top end of the implant is approximatelybetween 1.05 and 1.3. In one embodiment, a ratio of the diameter orother cross-sectional dimension of the bottom end of the implant to thediameter or other cross-sectional dimension of the top end of theimplant is at least 1.1.

According to some embodiments, a hydrogel implant configured forimplantation within a joint of a patient comprises a top end configuredto form an articulation surface when properly implanted within a joint,a bottom end generally opposite of the top end and a main hydrogel bodyextending between the top end and the bottom end and having alongitudinal centerline. In one embodiment, a diameter of the bottom endis greater than a diameter of the top end. The implant additionallycomprises side walls that generally extend between the top end and thebottom end, wherein the side walls are generally sloped relative to thelongitudinal centerline of the implant. In some embodiments, the implantcomprises a tapered shape or frustum due to, at least in part, to adifference between the diameters of the top end and the bottom end. Inone embodiment, the implant is configured for placement within animplant site having a similar reverse tapered, wedge or truncated coneshape or frustum, thereby reducing the likelihood of unintentionalremoval of the implant from the implant site following implantation.

According to some embodiments, the hydrogel comprises polyvinyl alcohol(PVA), saline, water, another hydrogel material, another polymericmaterial and/or any other substance or additive. In some embodiments,the content of PVA in the implant is approximately 20% to 60% by weight.In one embodiment, the content of PVA in the implant is approximately40% by weight. In some embodiments, the implant is generally loadbearing and/or configured for long term implantation within a patient.In one embodiment, the implant is generally non-biodegradable.

According to some embodiments, the joint implant is configured forplacement within a toe, finger, ankle, knee, shoulder, hip and/or anyother joint. In one embodiment, a transition between the top end and theside walls is generally curved or otherwise smooth. In some embodiments,the top end of the implant is approximately 5 mm to 20 mm in diameter.In some embodiments, a diameter of the bottom end is approximately 5% to15% (e.g., about 10%, 11%, 12%, 13%, 14%, 15%, etc.) larger than adiameter of the top end of the implant. In some embodiments, a distancebetween the top end and the bottom end of the implant is approximately 4mm to 16 mm.

According to some embodiments, a method of treating a joint of a patientcomprises creating a recess in a bone located at or near a targetedjoint, wherein the recess includes a generally wedge or truncated coneshape. In one embodiment, the recess in a bone comprises a surfaceopening along an outer surface of the bone and a bottom opening alongthe distal end of the recess, such that a diameter of the surfaceopening is generally smaller than a diameter of the bottom opening. Themethod additionally comprises providing a joint implant having a wedgeor truncated cone shape, wherein a diameter of a top end of the jointimplant is generally smaller than a diameter of a bottom end of thejoint implant. The method further includes inserting the joint implantwithin the recess so that the bottom end of the joint implant isadjacent to the bottom opening of the recess. In some embodiments, thediameter of the bottom end of the joint implant is larger than thediameter of the surface opening of the recess. In some embodiments, thesize of the implant matches or substantially matches the size of therecess. In some embodiments, the size of the implant is larger (e.g.,nominally, significantly, etc.) than the size of the recess.Accordingly, in such arrangements, the implant remains at leastpartially radially compressed within after implantation into the targetrecess or other implant site. The amount of radial compression in theimplant after implantation into the recess can vary from approximately0% to about 20% (e.g., about 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, valuesbetween the foregoing percentages, etc.). In one embodiment, forexample, the compression ratio of an implant is approximately 10%,wherein the diameter (or other cross sectional dimension) of the recessbase is about 90% of the base or bottom diameter of the implant.

According to some embodiments, the step of creating a recess in a bonecomprises using a drill bit comprising an articulating cutter configuredto create the generally wedge or truncated cone shape in the recess. Inone embodiment, the joint implant is inserted within the recess using anintroducer. In some embodiments, the joint implant is urged through aninterior of the introducer using a plunger or other pusher member (e.g.,manually or with the assistance of mechanical, hydraulic, pneumatic orother externally driven device). In some embodiments, the implantcomprises a hydrogel (e.g., PVA). In some embodiments, the recess islocated within a toe, finger, ankle, knee, shoulder, hip or any otherjoint.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentapplication are described with reference to drawings of certainembodiments, which are intended to illustrate, but not to limit, thevarious inventions disclosed herein. It is to be understood that theattached drawings are for the purpose of illustrating concepts andembodiments of the present application and may not be to scale.

FIG. 1 schematically illustrates a side view of a tapered implantaccording to one embodiment;

FIG. 2 schematically illustrates a side view of the implant of FIG. 1positioned within a corresponding implant site, according to oneembodiment;

FIG. 3A illustrates a side view of a tapered implant according to oneembodiment;

FIG. 3B illustrates a top view of the tapered implant of FIG. 3A;

FIG. 4 illustrates a top view of an open mold assembly for makingtapered implants, according to one embodiment;

FIGS. 5 and 6 illustrate side views of the mold assembly of FIG. 4;

FIG. 7 illustrates a perspective view of a drill bit configured for usewith a bone drill, according to one embodiment;

FIGS. 8A and 8B illustrate side views of the drill bit of FIG. 7;

FIG. 8C illustrates a distal end view of the drill bit of FIG. 7;

FIG. 8D illustrates a cross sectional view of the proximal shaft portionof the drill bit of FIG. 7;

FIG. 8E illustrates a detailed side view of the distal working end ofthe drill bit of FIG. 7;

FIG. 9A illustrates a side view of one embodiment of a drill bit with anarticulating cutter in a stowed or retracted orientation;

FIG. 9B a distal end view of the drill bit of FIG. 9A;

FIG. 9C illustrates a side view the drill bit of FIG. 9A with itsarticulating cutter in an extended or deployed orientation;

FIG. 9D a distal end view of the drill bit of FIG. 9C;

FIG. 10A illustrates a side view of one embodiment of a drill bit withan articulating cutter in a stowed or retracted orientation;

FIG. 10B a distal end view of the drill bit of FIG. 10A;

FIG. 10C illustrates a side view the drill bit of FIG. 10A with itsarticulating cutter in an extended or deployed orientation;

FIG. 10D a distal end view of the drill bit of FIG. 10C;

FIG. 11 illustrates a perspective view of an implant introduceraccording to one embodiment;

FIG. 12A illustrates a side view of the introducer of FIG. 11;

FIG. 12B illustrates a longitudinal cross-sectional view of theintroducer of FIG. 11;

FIG. 13A illustrates a distal end view of the introducer of FIG. 11;

FIG. 13B illustrates a detailed view along the neck portion of theintroducer depicted in FIG. 11;

FIG. 14 illustrates a longitudinal cross-sectional view of anotherembodiment of an implant introducer;

FIGS. 15A-15C illustrate time-sequential side views of an implant beinginserted within an implant site using the introducer of FIG. 11;

FIG. 16A illustrates a perspective view of an assembled implant deliverytool according to one embodiment;

FIG. 16B illustrates an exploded view of the delivery tool of FIG. 16A;

FIG. 16C illustrates a cross-sectional view of the delivery tool of FIG.16A;

FIG. 16D illustrates a perspective view of an assembled implant deliverytool according to one embodiment;

FIG. 16E illustrates an exploded view of the delivery tool of FIG. 16D;

FIG. 17A illustrates a perspective view of an introducer;

FIG. 17B illustrates a cross-sectional view of the introducer of FIG.17A;

FIG. 18 illustrates a side view of a plunger;

FIG. 19A illustrates a perspective view of a handle;

FIG. 19B illustrates a top view of the handle of FIG. 19A;

FIG. 20A illustrates a side view of a clamp;

FIG. 20B illustrates another view of the clamp of FIG. 20A; and

FIGS. 21A-21C illustrate sequential views of an implant being movedthrough and deployed from a delivery tool.

DETAILED DESCRIPTION

The discussion and the figures illustrated and referenced hereindescribe various embodiments of a cartilage implant, as well as varioustools, systems and methods related thereto. A number of these devicesand associated treatment methods are particularly well suited to replacedeteriorated or otherwise damaged cartilage within a joint. Suchimplants are configured to remain within the patient's joint on along-term basis (e.g., for most or all of the life of the patient), andas such, are configured, in some embodiments, to replace nativecartilage. Thus, in some embodiments, the implants are configured to besubstantially non-biodegradable and/or non-erodable. In someembodiments, for example, an implant is configured to remain within thepatient's joint or other portion of the anatomy for a minimum of 20 to100 years (e.g., about 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75,80, 85, 90, 95, 100 years, durations between the foregoing values, etc.)without losing its structural and/or physical properties and/or withoutlosing its ability to function as a cartilage replacement component ordevice. In other embodiments, the implants are configured to remainwithin the anatomy for greater than 100 years without losing itsstructural and/or physical properties and/or without losing its abilityto function as a cartilage replacement component. Accordingly, suchembodiments can be used to treat osteoarthritis, rheumatoid arthritis,other inflammatory diseases, generalized joint pain and/or other jointdiseases. However, the various devices, systems, methods and otherfeatures of the embodiments disclosed herein may be utilized or appliedto other types of apparatuses, systems, procedures and/or methods,including arrangements that have non-medical benefits or applications.

FIG. 1 schematically illustrates one embodiment of an implant 10intended for placement within or near a joint of a patient (e.g., toe,finger, ankle, knee, hip, shoulder, etc.). As shown, the implant 10 caninclude a generally tapered overall shape, wherein its base surface 14is larger than the opposite, top surface 16. As discussed in greaterdetail below, the smaller, top surface 16 can comprise the articulationsurface (e.g., a surface that is at least partially exposed to a joint),whereas the larger bottom or base surface 14 is securely retained withina corresponding opening specially created in the anatomy (e.g., throughbone, cartilage, other native tissue, etc.). As a result of such adesign, the sides 18 of the implant 10 can comprise a taper angle Θ(e.g., relative to generally vertical sides), thereby giving the implanta generally truncated cone or frustum-like shape. As discussed ingreater detail herein, such a reverse-taper, wedge or truncated coneshape can help ensure proper securement of the implant 10 within apatient's anatomy.

FIG. 2 schematically illustrates an implant 10 similar to the onedepicted in FIG. 1 snugly positioned within a corresponding recessedarea R of a patient's tissue T (e.g., bone, cartilage, etc.). In someembodiments, such a recessed area R is formed at or near the patient'sjoint so that the implant 10 can be used to replace and/or augmentdamaged cartilage (e.g., on a long-term or permanent basis, as discussedabove). Alternatively, however, the implant 10 can be positionedgenerally away from a joint or other articulation surface. Thus, any ofthe implant embodiments disclosed herein, or equivalents thereof, can beused in a human or animal anatomy for a variety of different indicationsor other purposes, such as, for example, joint therapy, reconstructivesurgery, tissue augmentation, cosmetic surgery and/or the like. For anyof the embodiments disclosed herein, or equivalents thereof, the implant10 can be load bearing or non-load bearing, as desired or required. Insome embodiments, once implanted within the anatomy, the implant 10 isconfigured to be non-biodegradable for at least the expected useful lifeof the implant 10. In some embodiments, the implant 10 is adapted togenerally retain its general structure, shape, structure, size,strength, compressibility, function and/or other properties during thelife of the patient into which the implant is inserted. For example, theimplant 10 can be configured to generally maintain its originalphysical, chemical, biocompatibility and/or characteristics for at leastabout 100 years. In some embodiments, the implant retains the same orsubstantially the same water content, resiliency, durability, strength,coefficient of friction and/or any other properties for the period oftime that it is positioned within the anatomy of the patient. In otherembodiments, the implant 10 is configured to generally maintain itsoriginal physical, chemical, biocompatibility and/or characteristics forless or more than about 100 years (e.g., about 50 years, 60 years, 70years, 80 years, 90 years, 110 years, 120 years, 130 years, 150 years,200 years, more than about 200 years, less than about 50 years, etc.),as desired or required. In some embodiments, the implant 10 isconfigured to resist or substantially resist biodegradation or massreduction during such target time period.

With continued reference to FIG. 2, during delivery of the implant 10within the recess, the implant 10 can be compressed inwardly (e.g., asschematically depicted by the arrows 20). At least some methods ofdelivering such implants within an appropriately sized and shaped recessare discussed in greater detail herein. In some embodiments, once theimplant 10 has been properly positioned within the recess R, the implant10 is permitted to expand outwardly, thereby filling in or otherwiseencompassing all or substantially all of the volume of the recess R. Insome embodiments, the diameter or other cross-sectional dimension of thebase 14 of the implant 10 is greater than the corresponding diameter orother cross-sectional dimension of the recess R. This helps prevent theimplant 10 from moving out of the recess after implantation. The reversetapered shape of the implant 10 and the recess R into which it is placedcan help ensure that implant 10 remains securely within the recess Rfollowing implantation. In some embodiments, the outwardly directedforces of the implant 10 in the direction of the adjacent interiorsurfaces of the recess R assist in maintaining the implant 10 within therecess R during use (e.g., after implantation).

According to some embodiments, the base (or bottom) 14 and/or the top 16of the implant 10 is generally circular. Alternatively, the shape of theends 14, 16 can be different than circular, such as, for example, oval,square, other rectangular, other polygonal, irregular and/or the like.Further, once securely implanted in a patient's anatomy (e.g., within arecess R), the top 16 of the implant 10 can be generally flush with theadjacent tissue surface. However, in other embodiments, the top 16 ofthe implant 10 extends above the adjacent tissue T (e.g., as illustratedin FIG. 2) or below the adjacent tissue T following implantation. Forexample, in one embodiment, the top 16 of the implant is slightly“proud” or raised relative to the adjacent tissue (e.g., cartilage) inorder to reestablish a desired contour of the damaged joint surface. Insome embodiments, such a raised or otherwise protruding configurationcan assist in creating a smoother transition between the exposed surfaceof the implant 10 and adjacent native cartilaginous surfaces of a joint.

The top and/or bottom surfaces 16, 14 of the implant 10 can be generallyflat or planar. In other embodiments, the surface 16, 14 can benon-planar (e.g., curved, domed, convex, concave, fluted, ridged, etc.),as desired or required. The shape of the top and/or bottom surfaces canbe selected based on a patient's anatomy, the location within thepatient's anatomy in which the implant will be placed and/or one or moreother factors or considerations. For example, the implant can beconfigured to generally or specifically match the slopes, contoursand/or other features of the patient's existing cartilaginous and/orbone tissue, the recess and/or the like. Accordingly, the function of arehabilitated joint or other targeted anatomical region being treatedcan be improved.

Another embodiment of a tapered implant 110 configured to replace oraugment damaged cartilage within a patient is illustrated in FIGS. 3Aand 3B. As shown, the implant 110 can comprise a bottom or base surface114 and a top surface 116, which is at least partially exposed toadjacent anatomical tissues (e.g., other cartilaginous surfaces, bone,other portions that function as an articulating surface of a joint,etc.) after implantation. As with the implant of FIGS. 1 and 2, thedepicted embodiment includes a base 114 that is generally wider orotherwise larger than the top surface 116. For example, the diameter orother comparable cross-sectional dimension of the base can be largerthan that of the top. Accordingly, the implant 110 can include generallysloped sides 118 that terminate in a top surface 116 of small diameter(or other cross sectional dimension) than that of the base or bottomsurface 114. The sloped surfaces can be generally flat or curved, asdesired or required. Further, as shown in FIG. 3A, the transitionbetween the sides 118 and the top 116 can be rounded or otherwisesmooth. However, the transition from the side surfaces 118 to the top116 of the implant 110 can be more or less smooth than illustrated inFIG. 3A. In other words, in some embodiments, the radius of the curvedcorners is larger or smaller than disclosed herein. For example, asschematically illustrated in FIG. 1, an implant can comprise generallysharp transitions between the top surface and the sides.

As discussed herein with reference to FIGS. 1 and 2, the top, bottomand/or side surfaces of the implant 110 can be generally planar (e.g.,flat) or non-planar (e.g., curved, concave, convex, undulating, fluted,etc.), as desired or required. Further, although not illustrated in FIG.3A, the recess or other opening in which the implant 110 will bepositioned can include a similar reverse-tapered shape (e.g., having awider or large base and a smaller top) to help ensure that the implant110 remains securely in place following implantation. Additional detailsregarding reverse tapered openings within a patient's anatomy (e.g.,bone), including details related to tools and methods that help createsuch openings, are provided below.

With continued reference to FIGS. 3A and 3B, an implant 110 can includea generally circular or oval cross-sectional shape. Thus, in someembodiments, the implant 110 is generally shaped like a frustum,truncated cone, cylinder and/or the like. However, the overall shape ofany of the implants disclosed herein can vary depending on the specificapplication or use. For example, the shape of the base (or bottom), topand/or any other cross-sectional area of an implant can be generallyrectangular (e.g., square), other polygonal, irregular and/or the like.

Regardless of its exact size and shape, the base portion can be largeror wider than the top of the implant in order to help ensure that theimplant remains securely positioned within a targeted portion of apatient's anatomy (e.g., a joint) following implantation. For example,in some embodiments, the dimension (or area) of the base or bottom ofthe implant is approximately 10% to 15% (e.g., about 10%, 11%, 12%, 13%,14%, 15%, ranges between such values, etc.) longer, wider or otherwiselarger than the top of the implant. Thus, in embodiments havinggenerally circular bottom and top surfaces, such as, for example, theimplant 110 illustrated in FIGS. 3A and 3B, the diameter of the base orbottom 114 is approximately 10% to 15% (e.g., about 10%, 11%, 12%, 13%,14%, 15%, ranges between such values, etc.) larger than the diameter ofthe top 116. In other embodiments, the base 114 can be more than about15% larger or less than about 10% larger than the top 116, as desired orrequired. For example, in some embodiments, the diameter (or othercross-sectional dimension) of the base 114 is larger than the diameter(or other cross-sectional diameter) of the top 116 by approximately 1%,2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, less than 1%, other values between theforegoing percentages and/or the like. Alternatively, the diameter (orother cross-sectional dimension) of the base 114 is larger than thediameter (or other cross-sectional diameter) of the top 116 byapproximately 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 50%, 60%,more than 60% and/or the like. According to some embodiments, for any ofthe implant arrangements disclosed herein, the ratio of the diameter (orother cross-sectional dimension) of the base 114 to the diameter (orother cross-sectional dimension) of the top 116 of the implant isbetween about 1 and about 1.3 (e.g., approximately or more than 1.05,1.06, 1.07, 1.08, 1.09, 1.1, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17,1.18, 1.19, 1.2, 1.21, 1.22, 1.23, 1.24, 1.25, 1.26, 1.27, 1.28, 1.29,1.3, values between the foregoing ratios, etc.). In other embodiments,the ratio is between about 1 and 1.05 (e.g., approximately or greaterthan 1.01, 1.02, 1.03, 1.04, 1.05), or greater than about 1.3 (e.g.,approximately or more than 1.3, 1.35, 1.4, 1.45, 1.5, 1.55, 1.6, greaterthan 1.6, etc.), as desired or required.

As discussed above with reference to the embodiments illustrated inFIGS. 1-3B, an implant having a wedge or reverse tapered design (e.g.,an implant having a larger base than top) can help prevent or reduce thelikelihood of unintended ejection or other escape from the implant siteafter implantation. Thus, in some embodiments, the push-out force (e.g.,the force necessary to eject or otherwise remove the implant from theimplant site) is advantageously increased for wedge shaped implantsrelative to implants that do not include a wedge or reverse taper design(e.g., cylindrical implants, right angle implants, implants havinggenerally vertical sides, etc.). As a result, the likelihood ofmaintaining such embodiments within a joint or other part of the anatomyafter implantation is advantageously increased.

With continued reference to FIG. 2, the implant can be positioned withina recess or other opening formed within the patient's bone, cartilage orother tissue. As shown, in some embodiments, the implant 10 is sized,shaped and otherwise configured to fill all or most of the volume of therecess R once properly inserted therein. Further, according to someembodiments, the implant is radially oversized relative to thecorresponding implant site (e.g., recess, opening, etc.) into which itwill be placed. For example, an implant can be radially oversized byapproximately 5% to 15% (e.g., about 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%,13%, 14%, 15%, other percentages between such values, etc.) relative tothe implant site. In alternative embodiments, an implant can be radiallyoversized by less than about 5% or more than about 15%, as desired orrequired. In such oversized embodiments, once implanted, the implant canexert a radial or other outwardly directed force on the correspondingrecess. In some embodiments, such a configuration can help ensure thatthe implant remains securely within the recess after implantation. Inyet other embodiments, the implant comprises a similar or identical sizeas the implant site or is generally radially undersized relative to theimplant site.

As a result of the shape of the implant and the corresponding implantsite (e.g., recess, other opening, etc.), it may be necessary toradially compress the implant (e.g., inwardly, as schematicallyillustrated by the arrows 20 in FIG. 2) in order to insert the implantwithin the implant site. Accordingly, one or more introducers or otherdelivery tools can be used to facilitate the placement of a taperedimplant within an implant site. Additional inwardly-directed compressiveforces on the tapered implant may be required for implants that areradially oversized relative to the target implant site, as discussedabove. The degree to which an implant can be compressed (e.g.,circumferentially, radially inwardly, etc.) may depend on one or morefactors, properties, characteristics and/or other considerations, suchas, for example, implant size, water content, ingredients and othercomponents, strength, elasticity, surrounding temperature, method ofmanufacturing and/or the like.

According to some embodiments, radial compression of an implant canaffect the implant's overall height, the shape or contours of its outersurfaces (e.g., top or articulating surface, base or bottom surface,sides, etc.) and/or one or more other properties or characteristics ofthe implant. By way of example, in some embodiments, radial compressionof an implant causes the height of the implant to increase (e.g.,relative to the height of the implant when it is not radiallycompressed). Consequently, careful consideration may need to be given tothe design of the implant based on, among other things, the expectedlevel of radial compression that may occur once the implant has beenproperly secured within the implant site. Therefore, the amount ofradial compression, and thus its effect on the implant's diameter,height, other dimensions, shape and/or other properties, may need to becarefully determined prior to implantation. Otherwise, uponimplantation, an implant may not properly align with adjacent cartilageor other tissue surfaces in a joint or other anatomical location.

According to some embodiments, any of the implant embodiments disclosedherein comprise polyvinyl alcohol (PVA) hydrogels. The implants cancomprise one or more other materials, either in addition to or in lieuof PVA, such as, for example, other hydrogels, other polymericmaterials, other additives and/or the like. In some embodiments, the PVAcontent of a hydrogel is approximately 40% by weight. However, the PVAcontent of an implant can be less or more than about 40% by weight(e.g., approximately 10%, 15%, 20%, 25%, 30%, 32%, 34%, 36%, 37%, 38%,39%, 41%, 42%, 43%, 44%, 46%, 48%, 50%, 55%, 60%, 65%, 70% by weight,less than about 10% by weight, more than about 70% weight, valuesbetween the foregoing ranges, etc.), as desired or required.

Further, the implants can comprise water, saline, other liquids,combinations thereof and/or the like. In some embodiments, the use ofsaline within a hydrogel implant may be preferred over water, because,under certain circumstances, saline can help maintain osmotic balancewith surrounding anatomical tissues following implantation. The exactcomposition of an implant (e.g., PVA or other hydrogel materials, water,saline or other liquids, other additives, etc.) can be selected so as toprovide the resulting implant with the desired or required strength,load bearing capacity, compressibility, flexibility, longevity,durability, resilience, coefficient of friction and/or other propertiesand characteristics.

In several embodiments, the implants disclosed herein are configured fordrug delivery and/or are seeded with growth factors and/or cells. Insome embodiments, the implants comprise one or more of the following:chondrocytes, growth factors, bone morphogenetic proteins, collagen,hyaluronic acid, nucleic acids, and stem cells. Such factors and/or anyother materials included in the implant and selectively delivered to theimplant site can help facilitate and promote the long-term fixation ofthe implant within the joint or other target area of the anatomy.

In some embodiments, the implants disclosed herein are configured foranchoring during implantation. The implant can comprise one or moreanchor sites (which may comprise non-hydrogel portions or tabs) tofacilitate anchoring (e.g., suturing, stapling, etc.). In oneembodiment, the implant is pre-coupled to one or more anchors. Suchanchors can comprise removable and/or permanent fixtures. In someembodiments, the anchors are resorbable or otherwise dissolvable afterimplantation (e.g., following a particular time period, such as, forinstance, 1-30 days, 2-30 weeks, 6-12 months, 1-5 years, greater than 5years, less than 1 day, etc.). In one embodiment, the implant comprisesat least one abrasive surface. In one embodiment, the implant comprisesone or more adhesive components. In other embodiments, the tapered shapeof the implant permits secure implantation without the need for anyanchoring or other fixation. In some embodiments, for any of theimplants disclosed herein, one or more implant surfaces can beconfigured to promote bone adhesion by one or more coatings, substancesand/or the like and/or by using an appropriate surface texture along thesurface(s). For example, the implant surface can be roughened, caninclude pores (e.g., superficial pores) and/or any other feature, asdesired or required.

In some embodiments, the implants disclosed herein are supported orreinforced by a rigid support frame, such as a ceramic or metallicframe. In some embodiments, the implants disclosed herein are supportedor reinforced by a flexible or rigid mesh structure. In otherembodiments, the implants do not contain any support or reinforcementstructure.

Any of the implant embodiments disclosed herein, or equivalents thereof,can be manufactured using freeze/thaw cycling and/or any otherproduction method. For example, a hydrogel formulation comprising water,saline, PVA (and/or other hydrogel materials), other polymericmaterials, other additives and/or the like can be heated and/orotherwise treated as part of a freeze/thaw manufacturing process. In oneembodiment, a hydrogel solution comprising saline and about 40% PVA byweight is heated to approximately 121° C. under elevated pressureconditions (e.g., to affect dissolution of the polymer). For example,such a solution can be autoclaved in order to facilitate complete orsubstantially complete dissolution of the PVA in the saline, waterand/or other liquid. Next, the temperature and/or pressure of thesolution can be lowered to permit entrapped air and/or other gases toescape. In one embodiment, after the autoclaving or similar step, thesolution is generally maintained at a temperature of approximately 95°C. and atmospheric pressure for a predetermined time period.

The solution can then be transferred (e.g., pumped, poured, etc.) intoopen molds where, once set, will form the desired shape of the implants.One embodiment of such an open mold assembly 200 is illustrated in FIGS.4-6. As shown, the open mold assembly 200 can include a plurality ofindividual mold cavities 210, each of which is configured to receive ahydrogel solution. With specific reference to the cross sectional viewsof FIGS. 5 and 6, in some embodiments, the hydrogel solution isconfigured to fill only a lower portion 216 mold's assembly cavities210. Alternatively, the cavities can be filled with the desired hydrogelsolution to a level that is above the lower portion 216. Accordingly,under such circumstances, the resulting device that is formed thereinwill extend into the upper portion 212 of the cavity 210. As describedin greater detail below, any part of the device that extends above thelower portion 216 can be removed in order to produce an implant havinggenerally sloped or contoured side walls and a reverse tapered design,in accordance with various implant arrangements disclosed herein.

With continued reference to FIGS. 4-6, the cavities 210 of the moldassembly 200 can be shaped, sized and otherwise configured so that theimplants formed therein comprise a wedge, truncated cone or reversetaper design. For example, in such designs, the base ends of theimplants are generally larger than the corresponding, opposite top ends.Once the implants have been molded, they can be removed from the upperends of the assembly 200. The molded items can be removed either afterinitial formation or after they undergo additional treatment (e.g.,freeze/thaw cycling, other heat and/or pressure treatment, etc.). Asnoted above, depending on how much hydrogel solution is placed in thecavities, the molded implants removed from the cavities 210 of theassembly 200 may need to be cut, altered or otherwise processed. Forexample, in some embodiments, any portion of the implants formed by thegenerally cylindrical cavity section in the upper portion 212 of thecavities may need to be excised and discarded as part of a subsequentreshaping step. Accordingly, the remaining implants can generallyresemble the shape of the implant embodiment of FIGS. 3A and 3B or anyother implant having a generally reverse taper or wedge design.

Due in part to the remaining production steps, accommodation of anychanges in size (e.g., expansion, contraction, etc.) that may occur orare likely to occur to the implants can be considered duringmanufacturing by properly sizing and otherwise designing the moldassembly 200. The amount of contraction or expansion of the implants canbe based on one or more factors or conditions, such as, for example, thenumber of freeze/thaw cycles to which the implants are subjected, thetemperature and/or pressure ranges associated with the remaining stepsand/or the like.

Alternatively, the implants can be formed, at least in part, using aninjection molding process and/or any other molding or casting procedure.In such injection or transfer molding techniques, once the hydrogel orother implant solution has been prepared, it can be loaded into aninjection cylinder or other container of a molding press. The solutioncan then be forcibly transferred into a closed mold assembly using apneumatic or hydraulic ram or any other electromechanical device, systemor method. In some embodiments, the hydrogel and/or other solution orimplant component is injected into a corresponding closed mold assemblythrough a standard runner and gate system. Injection molding of implantscan provide one or more benefits relative to open mold assemblies. Forinstance, the devices formed as part of the injection molding techniquestypically do not require additional cutting, reshaping, resizing and/orprocessing, as they are essentially in their final shape immediatelyafter the injection molding step has been completed.

Regardless of how the implants are molded or otherwise shaped ormanufactured, they can be subsequently subjected to one or morefreeze/thaw cycles, as desired or required. In some embodiments, forexample, the implants, while in their respective mold cavities, arecooled using a total of four freeze/thaw cycles wherein the temperatureis sequentially varied between approximately −20° C. and 20° C. In otherembodiments, however, the number of freeze/thaw cycles, the temperaturefluctuation and/or other details related to cooling the implants can bedifferent than disclosed herein, in accordance with a specificproduction protocol or implant design.

Following freeze/thaw cycling, the implants can be removed from theirrespective mold cavities and placed in one or more saline and/or otherfluid (e.g., other liquid) baths where they can be subjected toadditional cooling and/or other treatment procedures (e.g., to furtherstabilize the physical properties of the implants). According to someembodiments, for instance, the implants undergo an additional eightfreeze/thaw cycles while in saline. In other embodiments, such follow-upcooling procedures are either different (e.g., more or fewer freeze/thawcycles, different type of bath, etc.) or altogether eliminated from theproduction process, as desired or required.

When the cooling (e.g., freeze/thaw cycling) and/or other treatmentsteps have been completed, the implants can be inspected to ensure thatthey do not include any manufacturing flaws or other defects. Further,at least some of the implants can be subjected to selective testing toensure that they comprise the requisite physical and othercharacteristics, in accordance with the original design goals and targetparameters for the implants. Further, it may be necessary to cut orotherwise process the implants in order to remove any excess portions.In some embodiments, the completed implants are packaged in hermeticallysealed plastic trays (or other containers) comprising foil or othertypes of lids or covering members. A volume of saline and/or otherliquid can be included within such trays or other containers to ensureproper hydration of the implants during storage and/or any other stepspreceding actual use. In one embodiment, the implant trays or othercontainers are terminally sterilized using e-beam exposure between about25 and 40 kGy. Additional details related to producing hydrogel implantscan be found in U.S. Pat. Nos. 5,981,826 and 6,231,605, the entiretiesof both of which are hereby incorporated by reference herein.

According to some embodiments, the overall height (e.g., between thebase or bottom surface and the top or articulating surface) of a taperedimplant is approximately 10 mm. Further, the diameter or othercross-sectional dimension along or near the top surface of the implantcan be about 10 mm. However, in other embodiments, the height, diameterand/or other dimensions of a wedge-type implant can vary, as desired orrequired. For example, implants adapted for use in larger joints (e.g.,knee, shoulder, hip, etc.) can have a height and/or diameter larger than10 mm (e.g., about 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 18 mm, 20mm, greater than 20 mm, dimensions between the foregoing values, etc.).Likewise, implants configured for use in smaller joints (e.g., toes) canbe smaller than 10 mm in height (e.g., about 2 mm, 4 mm, 6 mm, 8 mm)and/or 10 mm in top diameter (e.g., about 2 mm, 4 mm, 6 mm, 8 mm).

As discussed above with reference to FIGS. 1 and 2, in order to ensurethat the implant securely remains within a joint or other anatomicallocation following implantation, the implant can be positioned within animplant site that also comprises a similar reverse taper, wedge ortruncated cone shape. Accordingly, several embodiments of making such atapered recess or other opening within bone tissue are described ingreater detail below.

FIGS. 7-8B illustrate one embodiment of a drill bit 300 that can be usedto create a reverse taper recess into which an implant may bepositioned. As shown, the drill bit 300 can comprise a main body portion310 that extends at least partially along the longitudinal dimension ofthe drill bit 300. In the illustrated embodiment, the proximal end 320of the drill bit 300 comprises a shaft 322 that is sized, shaped andotherwise configured to selectively mate with a corresponding portion ofa bone drill (not shown). In the depicted embodiment, the shaft 322comprises a generally triangular cross-sectional shape, as shown in FIG.8D. However, in alternative arrangements, the shape, size and/or otherdetails of the shaft can vary. The shaft 322 can include a standard ornon-standard configuration. Bone drills with which the various drill bitembodiments disclosed herein are used can be either manually operated orpower driven (e.g., mechanically, pneumatically, hydraulically, etc.).

With continued reference to FIGS. 7, 8A and 8B, and as shown in thedetail view of FIG. 8E, a distal end 330 of the drill bit 300 caninclude a flange 340 and one or more abrading members or cutters 356extending distally from the flange 340. As best illustrated in the frontview of FIG. 8C, the drill bit 300 can comprise a total of three cutters356 that are generally equally spaced apart (e.g., at angles ofapproximately 120° relative to one another). In other embodiments,however, the quantity, size, shape, position, orientation, spacingand/or other characteristics or properties of the cutters 356 can bedifferent than illustrated herein. For example, in some arrangements, adrill bit can include more or fewer cutters (e.g., 1, 2, 4, 5, more than5), as desired or required. Likewise, the cutters can be larger orsmaller or can extend along different portions of the distal end of thedrill bit.

According to some embodiments, a drill bit can be cannulated, such thatone or more passages or openings 326 extend (e.g., longitudinally)through the device. For example, as illustrated in FIGS. 7 and 8A-8E,such a passage 326 can generally extend from the proximal end of thedrill bit 300 to the distal end, terminating in an opening 351 along thedistal hub 352 to which the cutters 356 are secured. As discussed ingreater detail below, the inclusion of such passages or openings 326 canhelp ensure that the drill bit is accurately positioned within apatient's joint or other portion of the anatomy before commencing adrilling procedure.

As the drill bit 300 is rotated (e.g., either manually or using one ormore external driving sources, etc.), sharp edges formed along thedistal and/or peripheral portions of the cutters 356 can abrade andremove cartilage, bone and/or other tissue that they engage and contact.In some embodiments, the longitudinal distance D1 (FIG. 8A) between thedistal face 341 of the flange member 340 and the distal ends of thecutters 356 can limit the depth of the recess or opening that is createdwithin the patient's bone or other anatomical area. Likewise, theperipheral surfaces of the cutters 356 can define a diameter or othercross-sectional dimension D2 (FIG. 8A) that effectively limits thediameter of the resulting recess or other openings in the patient's boneor other targeted tissue. Thus, each drill bit 300 can be configured tocreate an implant site having specific dimensions (e.g., depth,diameter, etc.). Consequently, in some arrangements, drill bits ofvarying size and shape are available to the surgeon or other clinicianin order to accurately create a specific desired implant site within thepatient. For any of the embodiments disclosed herein, the distal edgesand/or other surfaces of the cutting blades or cutters can be generallyflat and/or otherwise contoured (e.g., to generally match and/or receivethe base of the implant).

As the drill bit 300 is rotated and advanced into a targeted region ofthe patient's anatomy, abraded bone, cartilage and/or other tissueand/or other debris will be created at or near the distal end 330 of thedevice. Accordingly, in order to permit such debris to be removed fromthe treatment site, the flange 340 can include one or more openings 344.Thus, abraded materials can stay clear of and not interfere with theworking end of the drill bit, allowing the cutters 356 to continue tofunction normally. Once the distal face 341 of the flange 340 abuts thetop surface of the bone being drilled, further advancement of the drillbit 300 can be prevented. This alerts the clinician that the implantsite having the desired depth and diameter has been properly created.

With continued reference to the front view of FIG. 8C, the cutters 356can be joined along a hub 352 along or near the center of the distalface 341 of the flange 340. As shown, the cutters 356 can extend atleast radially outwardly from the central hub 352, toward the outerperiphery of the flange 340. As noted above, the radial length of thecutters 356 can help determine the diameter of the recess or openingthat will be created within a patient's bone or other tissue. In thedepicted embodiment, however, because of the generally verticalorientation of the peripheral edges 357 of the cutters 356, thecorresponding implant opening that will be created by the drill bit 300will be generally cylindrical. Therefore, additional implant sitepreparation is required in order to create an opening having a reversetaper shape.

Accordingly, a drill bit having an articulating cutter or a movablecutting arm can be used to create the necessary taper or slope along theside walls of the recess or opening in a bone or other targeted regionof the anatomy. In some embodiments, the articulating cutter isconfigured to create a curved contour along the bottom and/or sidesurfaces of the recess. For example, such curved surfaces can includeone or more convex and/or concave portions, as desired or required. Oneembodiment of a drill bit 400 configured to create such a reversetapered implant site is illustrated in FIGS. 9A-9D. Like the arrangementdiscussed above with reference to FIG. 7, the depicted drill bit 400 cancomprise a main body portion 410 that terminates at or near a distalflange assembly 440. Further, a proximal end of the drill bit 400 cancomprise a shaft 420 that is sized, shaped and otherwise configured toengage and mate with a corresponding portion of a drill (not shown). Inaddition, a central hub 452 located along on near the distal face 441 ofthe flange 440 can help secure one or more stationary cutters 456 thatare configured to abrade bone, cartilage and/or other tissue with whichthey come in contact. The arrangement illustrated in FIGS. 9A-9Dcomprises two stationary cutters 456 that are spaced generally oppositeof each other (e.g., 180° apart). However, in alternative embodiments, adrill bit comprises more or fewer stationary cutters, as desired orrequired.

With continued reference to FIGS. 9A and 9B, the drill bit 400 canadditionally comprise one or more articulating cutters or movablecutting arms 460. As discussed in greater detail herein, such a movablecutter 460 can be selectively deployed (e.g., radially outwardly about ahinge or other pivot point) in order to create a desired draft anglealong the side of the implant site. In FIGS. 9A and 9B, the articulatingcutter 460 is shown in the stowed or radially contracted position. Thus,as the drill bit is rotated and advanced into a bone, a generallycylindrical bore or opening will be created by the stationary cutters456. Once the drill bit 400 can been advanced sufficiently far into thetargeted bone or other site, the distal face 441 of the flange 440 willcontact and abut an exterior surface of the bone or other site beingdrilled. This can prohibit the continued advancement of the cutters 456and advantageously limit the depth of the resulting implant site.

According to some embodiments, once the stationary cutters 456 of thedrill bit 400 have created a generally cylindrical recess or openingwithin the patient's targeted bone or other site and the flange 440contacts a corresponding abutting surface, the surgeon or otherclinician can cause the articulating cutter 460 to be deployedoutwardly. Thus, the desired reverse taper or wedge shape can be createdalong the sides of the implant site. As shown in FIG. 9C, in oneembodiment, the articulating cutter 460 is moved outwardly byselectively retracting a sleeve 470 in the proximal direction (e.g.,away from the flange 440 and the distal end of the drill bit, asgenerally represented in FIG. 9C by arrow P). In some embodiments, thesleeve 470 includes a contoured grip portion 472 to allow the user tomore easily grasp and retract the sleeve 470. Consequently, thearticulating cutter 460 can be rotated or otherwise moved in a mannergenerally represented by arrow A. This permits the peripheral edge ofthe articulating cutter 460 to contact and abrade additional bone,cartilage and/or other tissue, thereby creating the desired reversetaper or truncated cone shape within the recess R (FIG. 2).

In some embodiments, once released outwardly (e.g., by retraction of thesleeve 470), the articulating cutter 460 can assume a fully extendedorientation in order to create the necessary taper to the adjacent sidewalls of the implant site. Thus, a sufficiently strong biasing or othertype of force can be imparted on the articulating cutter 460 to ensurethat it can reach the targeted fully deployed position. The articulatingcutter 460 can be biased radially outwardly using a spring or otherresilient member. Alternatively, any other force imparting device ormethod can be used to ensure that the articulating cutter 460 fullyextends when selectively deployed by the clinician. Once the necessarytaper along the sides of the implant site has been created, the sleeve470 can be returned to its original orientation (e.g., closer to theflange 440, as illustrated in FIG. 9A), causing the articulating cutter460 to move to its stowed or radially retracted position.

According to some embodiments, the sleeve 470 is normally resilientlybiased in the distal position (e.g., as illustrated in FIG. 9A). Thus,in such configurations, as discussed above, a surgeon or other userneeds to retract the sleeve 470 proximally relative to the main bodyportion 410 of the drill bit 400 in order to deploy the articulatingcutter 460. In one embodiment, as illustrated in FIG. 10A, the sleeve570 is normally maintained in a distal orientation with the assistanceof a spring 516 or other resilient member. In the illustratedembodiment, the sleeve 570 includes a body portion 572 and an enlargedgrip portion 574. A proximal end of the spring 516 can be coupled to astop nut 512 coupled to or integrally formed with the main body portion510. The sleeve 570 contacts the stop nut 512 to prevent furtherretraction once the articulating cutter 560 has been deployed. However,any other device or method can be used to normally maintain the positionof the sleeve 470, 570 relative to adjacent portions of the drill bit400, 500 (e.g., the main body portion 410, 510). For example, in someembodiments, the drill bit is configured to automatically deploy thearticulating cutter in a outwardly oriented position once the flange ofthe drill bit contact the outer surface of the bone structure or othertreatment site (e.g., once the cylindrical recess has been made to thedesired depth). In such arrangements, the articulating cutter can bedeployed in its expanded position as a result of automatic mechanicalactuation between the flange, cutter and/or other portion of the drillbit relative to the implant site.

In other embodiments, a reverse tapered recess can be created using atwo or multi-step process. For example, as part of an initial step, afirst drill bit can be used to create a generally cylindrical openingwithin a targeted bone. One embodiment of a drill bit that is configuredto only create a generally cylindrical opening is illustrated anddiscussed herein with reference to FIGS. 7 and 8A-8C. Then, once thefirst drill bit has been removed, a second drill bit having anarticulating arm, such as, for example, the bit discussed herein withreference to FIGS. 9A-9D and 10A-10D, can be inserted into the generallycylindrical opening. By moving the articulating cutter to its extendedposition, therefore, the desired wedge or reverse tapered shape can becreated within the recess or implant site.

With reference to FIG. 10A, a drill bit 500 can comprise a total ofthree stationary cutters 556 and an articulating cutter 560. However, inother arrangements, a drill bit can comprise more or fewer stationarycutters 556 and/or articulating cutters 560, as desired or required by aparticular application or use. Further, as depicted in FIG. 10C, thearticulating cutter 560 can attach to the main body 510 and/or any otherportion of the drill bit 500 using a hinge 564 or other pivot point.Thus, as discussed in greater detail above with reference to FIGS.9A-9D, the articulating cutter 560 can be selectively rotated about sucha hinge 564 between stowed and extended orientations. Accordingly, thedrill bits 400, 500 illustrated in FIGS. 9A-9D and 10A-10D can beadvantageously used to create an implant site having a desired reversetaper or wedge design. In other embodiments, drill bits comprisingarticulating cutters can be introduced into the implant site after agenerally cylindrical recess or opening has been created by a drill bitthat does not include an articulating cutter (e.g., the drill bit shownin FIG. 7), as part of a two-step procedure.

According to some embodiments, the drill bit can be advanced to thetargeted drill site of the patient bone or other anatomical locationwith the assistance of a guide pin. As discussed herein, any one of thedrill bit arrangements disclosed herein can include a longitudinal lumenor other passage. Thus, a guide pin can be tamped at least partiallyinto the surface of the bone to be drilled. The guide pin may beadvanced through the patient's anatomy using a trocar or similar device.Next, a cannulated drill bit, as discussed herein, can be passed overthe guide pin to ensure that the distal, working end of the drill bit isproperly positioned relative to the treatment site (e.g., joint).

Once a reverse taper implant site has been created in the targeted jointor other portion of the patient (and, where applicable, the guide pin orother member has been removed), a clinician can deliver the implant tothe implant site using an introducer 600. As illustrated in FIGS.11-13B, an introducer 600 can include a generally cylindrical introducertube 610 having an opening 620 through which the implant may be passed.In some embodiments, the distal end 606 of the introducer tube 610 cancomprise a neck or other narrowed portion 608. As shown in FIG. 13B, theneck portion 608 can include a wall 612 having a rounded distal edge613. In some embodiments, the neck portion 608 has a length (labeled 614in FIG. 12B) of about 0.155 inches to about 0.170 inches. Further, asbest illustrated in the longitudinal cross-sectional view of FIG. 12B,the internal diameter of the introducer tube 610 can vary along itslength. For example, in the depicted embodiment, a proximal portion 618of the introducer 600 comprises a flared shape, wherein the insidediameter of the opening 620 is progressively reduced in the proximal todistal direction. Further, as shown, the opening 620 can maintain agenerally constant inner diameter along a second, more distal portion616 of the introducer tube 610. In other embodiments, the innerdiameter, length, other dimension and/or other details or properties ofthe introducer 600, including its flared interior portion 628, itsgenerally cylindrical interior portion 626 of the introducer tube 610,its neck portion 608 and/or the like can be different than shown inFIGS. 11, 12A-12B and 13A-13B and described herein. By way of example,the embodiment illustrated in FIG. 14 comprises a longer flared interiorportion 728 (e.g., relative to the adjacent generally cylindricalportion 726) than the introducer 600 of FIG. 12B.

The neck portion 608 of the introducer tube 610 can be positioned atleast partially within the opening or recess into which the implant willbe secured. In some embodiments, the introducer can be sized, shaped andotherwise configured to that the neck portion 608 fits generally snuglywithin the implant site. With reference to FIGS. 15A-15C, an implant 10can be placed within the opening 628 along the proximal end 602 of theintroducer 600. As shown, in some embodiments, the implant 10 isadvanced into the interior of the introducer 600 with its base or bottom14 end first.

As the implant 10 is urged deeper (e.g., more distally) into theinterior of the introducer 600, the implant 10 may become radiallycompressed by the adjacent interior walls. If sufficient force isapplied to the implant 10, the implant 10 passes through the neckportion 608 of the introducer and into the implant site R. Asillustrated in FIG. 15C, in such an arrangement, the implant's base end14 will be located along the bottom of the implant site. According tosome embodiments, a plunger or other pusher member (not shown) can beinserted within the interior of the introducer to help push the implantthrough the introducer and into the implant site. Such a plunger orpusher member can be operated manually and/or with the assistance of anexternal power-assist device (e.g., mechanically, pneumatically,hydraulically, etc.), as desired or required.

According to some embodiments, once a reverse taper site has beencreated in the targeted joint or other portion of the patient (and,where applicable, the guide pin or other member has been removed), aclinician can deliver the implant to the implant site using amechanically-assisted delivery tool or introducer 800. One embodiment ofsuch a tool is illustrated in FIGS. 16A-16C. Another embodiment of sucha tool is illustrated in FIGS. 16D-16E. As shown, the delivery tool orintroducer 800 can comprise, among other things, an introducer tube 810,a plunger 820, a handle 830 and a clamp 840.

Such mechanically-assisted delivery devices can be helpful in advancingthe implant through the interior of an introducer tube against arelatively large resistance of back-pressure. Such a resistive force canbe particularly high when the implant comprises a relatively large taperangle Θ. Accordingly, in some embodiments, the use of such deliverytools makes the delivery of reverse taper implants into correspondingimplant sites possible, while allowing the clinician to safely andaccurately guide the implant into a targeted anatomical implant site. Inseveral embodiments, the delivery tool is capable of overcomingresistive forces of about 5 to about 20 pounds. In some embodiments, thedelivery tool exerts a force about 5 to about 25. In some embodiments,the delivery device is operated by or with the assistance of one or moremotors. For example, in some embodiments, the clamp is moved (e.g.,rotated) relative to the handle using (or with the assistance of) one ormore stepper motors and/or any other type of motor or actuator. In someembodiments, delivery of an implant through the introducer tube 810 isaccomplished with at least some assistance from air or pneumaticpressure. For example, air or other fluid can be injected into theinterior of the introducer tube once the implant is inserted therein.The delivery of air can be incorporated into a plunger member 820 (e.g.,via one or more interior lumens) so that the implant can be advancedthrough the introducer tube 810 into the implant site using mechanicalforce (e.g., by moving the plunger 820 through the tube 810) and/or byinjecting air and/or other fluids into the interior of the tube 810. Thefluid openings through the plunger 820 and/or any other fluid passagescan be placed in fluid communication with a compressor or other fluidgenerating device. Advancement of the implant through the introducertube 810 can be accomplished by applying a vacuum along or near thedistal end of the tube 810 (e.g., through one or more vacuum ports alongthe introducer tube 810). Such vacuum ports or openings can be placed influid communication with a vacuum or other suction generating device.

According to some embodiments, the delivery tool comprises one or moredepth stop features or components to ensure that the implant beingdelivered to a target implant site is properly delivered into the targetimplant site. In some embodiments, the depth stop features help protectthe structural integrity of the implant as the implant is being insertedwithin the target anatomical implant site.

In some embodiments, the delivery device comprises and/or is operativelycoupled to one or more pressure gauges or other pressure or forcemeasuring devices, members or features. Such gauges or other measurementdevices can help ensure that a maximum backpressure or force is notexceeded when operating the device. This can help protect the integrityof the implant (e.g., to ensure that the structural integrity, watercomposition and/or other properties of the implant are maintained),protect the delivery device, protect the user and/or the patient and/orprovide one or more other advantages or benefits.

According to some embodiments, the introducer tube 810 of the deliverytool or device 800 comprises one or more viewing windows that permit theimplant to be viewed as it is being advanced through the device 800 tothe implant site. In some embodiments, the introducer tube 800 (and thusthe longitudinal axis along which the implant is advanced through thedelivery tool or device) is substantially perpendicular with the surfaceof the bone or other anatomical site into which the implant will bedelivered and/or the handle 830 of the device 800.

According to some embodiments, at least a portion of the interior of theintroducer tube 810 comprises and/or is otherwise coated or lined withone or more absorbable or lubricious layers, materials and/or othersubstances. Such materials can help preserve the moisture level of theimplant as it is being advanced through the introducer tube 810. Theinterior surface of the introducer tube can comprise a low coefficientof friction to facilitate the delivery of an implant through thedelivery device or tool 800. In some embodiments, the effectivecoefficient of friction along the interior of the introducer tube can belowered polishing such surfaces. As noted herein, the introducer,including its interior surfaces, can comprise surgical grade stainlesssteel.

According to some embodiments, the delivery tool or device 800 isincorporated into the drill bit configured to create a reverse taperedimplant site. For example, such a combination device can be coupled to adrill or other mechanical device to first create the implant site. Then,the combination device can take advantage of the mechanical outputgenerated by the drill and/or other mechanical or motorized device tohelp urge the implant through the introducer tube of the combinationdevice.

As illustrated in FIGS. 17A and 17B, the introducer tube 810 of themechanically-assisted delivery tool 800 can be hollow and generallycylindrical in shape. However, in other embodiments, the shape, generalstructure and/or other characteristics of the tube 810 can be differentthan disclosed herein. In some embodiments, the introducer tube 810comprises an externally threaded portion 814, a proximal portion 812extending between a proximal end 802 and the externally threaded portion814, and a distal portion 816 extending between the externally threadedportion 814 and a distal end 804. The distal end 804 of the introducer810 can comprise a neck or other narrowed portion 806.

As best illustrated in the longitudinal cross-sectional view of FIG.17B, the internal diameter of the introducer tube 810 can vary along atleast a portion of the tube's length. For example, in the depictedembodiment, the proximal portion 812 of the introducer or introducertube 810 has a generally constant, consistent or flat inner diameter. Inaddition, as shown, the distal portion 816 of the introducer tube 810can comprise a generally tapered or sloped portion 816 a, such that theinside diameter of the tube is progressively reduced in the proximal todistal direction. In some embodiments, the slope along the interiorsurface of the tube 810 can be generally linear. However, in otherarrangements, the slope of the interior surface of the tube 810 is atleast partially non-linear (e.g., curved, rounded, irregular, etc.),either in addition to or in lieu of any generally linear and/or constantportions, as desired or required for a particular application or use.Further, in some embodiments, as illustrated in the cross-sectional viewof FIG. 17B, a portion 816 b proximate the distal end 804 comprises agenerally constant or flat (e.g., non-sloped) inner surface or diameter.Further, in other embodiments, the inner diameter or surface, length,other dimensions and/or other details or properties of the introducertube 810, including any internal tapered or sloped portions 816 a, anygenerally cylindrical (e.g., constant, flat, non-sloped, etc.) interiorportions 816 b, any neck portions 806 and/or the like can be differentthan shown in FIGS. 17A-17B and described herein.

According to some embodiments, the proximal portion 812 of theintroducer tube 810 includes one or more slits or other openings 818. Asshown, such a slit 818 can begin adjacent to or near the externallythreaded portion 814 of the tube 810 and can extend to or near theproximal end 802 of the tube 810. In some embodiments, the proximalportion 812 of the introducer tube includes two (or more) slits 818located opposite each other in the introducer 810 to form a channelthrough the proximal portion 812. In some embodiments, for example asshown in FIGS. 16D-16E, the proximal portion 812 of the introducer tube810 comprises a flange 819 or other protruding or flared portionextending outwardly (e.g., radially outwardly in a continuous orintermittent manner) from or near the proximal end 802. In otherembodiments, the flange or other protruding member 819 can be locatedalong one or more other longitudinal locations of the tube 810, asdesired or required. The flange 819 can be substantially or generallyflat and/or can include any other shape (e.g., curved, fluted, etc.).The flange 819 can be integrally formed or attached to the proximalportion 812 of the tube 810. Alternatively, the flange 819 can be aseparate member that can be selectively attached to or removed from thetube 810 and/or any other portion of the tool 800.

With reference to FIG. 18, the plunger 820 of the tool 800 can begenerally cylindrical in shape with an enlarged proximal head portion822 that includes a domed proximal end 824. In some embodiments, in aproperly assembled mechanically-assisted delivery tool 800, the plunger820 is shaped, sized and otherwise configured to slide within the hollowinterior passage of the introducer tube 810. Thus, as discussed ingreater detail herein, by actuating the tool, a clinician or other usercan selectively move the plunger within an interior portion of theintroducer tube 810 in order to urge an implant (e.g., a taperedimplant) through the distal end of the tube and into a targeted implantsite of a patient.

With continued reference to FIG. 18, the main body 826 of the plunger820 can have a diameter approximately the same as and/or slightlysmaller than the inner diameter of the neck portion 806 and distalportion 816 b of the introducer 810. In some embodiments, as illustratedin the embodiment of FIG. 16E, the head portion 822 of the plunger 820includes a motion limiter or depth stop 828. The motion limiter 828 cancomprise one or more knobs, protrusion members and/or other members orfeatures that generally extend outwardly from the head portion 822 ofthe plunger. In some embodiments, such a motion limiter, depth stopmember or feature and/or other protruding member 828 is configured toslide within the slit(s) 818 or other openings of the introducer tube810. These features can help prevent or otherwise limit distal movementof the plunger 820 relative to the introducer tube (e.g., when themotion limiter or depth stop 828 contacts or abuts the base of theslit(s) 818). Further, such a feature can help prevent or limit rotationof the plunger relative to the tube 810 during use. In some embodiments,the head portion 822 of the plunger 820 comprises a diameterapproximately the same as and/or slightly smaller than the innerdiameter of the proximal portion 812 of the introducer tube 810.Accordingly, movement of the plunger 820 relative to the tube 810,beyond a particular point, will generally be prevented or limited whenthe head portion 822 contacts or abuts the narrowing inner diameter ofthe tapered portion 816 a of the distal portion 816 of the introducertube. Therefore, the corresponding abutting features of the plunger 820and the introducer tube 810 can advantageously help limit the depth towhich an implant (e.g., tapered implant) can be delivered relative to animplant site of a patient. In some embodiments, this can help improvethe safety and efficacy of the implant, the related tools and theimplant procedure.

According to some embodiments, as illustrated in FIG. 19A, the handle830 of the delivery tool 800 comprises a generally circular internallythreaded nut portion or introducer tube receiving portion 834. As shown,the threaded nut portion or introducer tube receiving portion 834 can beinterposed between an elongate proximal section 832 and an elongatedistal section 836. In the depicted arrangement, the introducer tubereceiving portion 834 is located closer to the distal section 836 of thehandle 830. However, in other embodiments, the portion 834 can belocated along any other portion of the handle 830, as desired orrequired. Further, the introducer tube receiving portion 834 can includeone or more other engagement or connection features or devices (e.g.,snap connections, press-fit or friction-fit connections, screws or otherfasteners, adhesives, etc.), either in lieu of or in addition to athreaded connection.

With continued reference to the perspective view of the handleillustrated in FIG. 19A, the proximal portion or section 832 of thehandle can be longer than the distal portion or section 836. In otherwords, as noted above, the introducer tube receiving portion 834 can bepositioned closer to the distal end than the proximal end of the handle830. However, in other embodiments, the introducer tube receivingportion 834 is located at or near between the distal and proximal endsof the handle, or at, near or closer to the proximal end of the handle,as desired or required.

As shown in FIG. 19A, the proximal section 832 and distal section 836can extend in generally opposite directions from the nut or introducertube receiving portion 834. However, in some embodiments, a longitudinalaxis of the distal section 836 is slightly offset from a longitudinalaxis of the proximal section 832. Such a configuration can assist withthe coupling of the clamp 840 as described herein. For example, in theillustrated embodiment (e.g., when viewed from the top as shown in FIG.19B), a centerline or orientation of the distal section or portion 836of the handle is generally offset with respect to the centerline ororientation of the proximal section 832. The introducer tube receivingportion 834 can be sized, shaped and otherwise configured so that thedistal section 816 of the introducer tube 810 can pass through theopening of the introducer receiving portion 834. Further, the externallythreaded portion 814 of the introducer tube 810 can operatively engageand mate with the internal threaded portion of the introducer tubereceiving portion 834. As noted above, in other embodiments, the handle830 can engage the introducer tube 810 using one or more otherattachment methods, features or devices (e.g., fasteners, snap-fit orfriction-fit connections, other mating connections or couplings,adhesives, etc.) either in addition to or in lieu of a threadedconnection.

In some embodiments, the elongate proximal section or portion 832 of thehandle comprises a grasping portion 838 configured to be selectivelygripped and manipulated by a user during use. The grasping portion 838can be contoured, shaped and/or otherwise configured to improve theuser's grip on the handle 830. In the illustrated embodiment, the distalsection or portion 836 of the handle comprises a generally rectangularcross-section. However, the distal portion and/or any other portion ofthe handle 830 can include any other shape (e.g., circular, oval,square, polygonal, etc.). When the nut portion of introducer receivingportion 834 is oriented horizontally, the distal section 836 of thehandle comprises a generally vertical shape so that it is taller than itis deep.

According to some embodiments, the distal section 836 of the handle 830comprises a keyhole 837 or other opening for coupling to the clamp 840of the device. The keyhole 837 or other opening can be configured toallow the clamp 840 to be quickly and easily connected to and/ordisconnected from the handle 830. In other arrangements, however, theclamp 840 can be permanently or substantially permanently attached tothe handle 830. In other embodiments, the size, shape, orientation,and/or other details or properties of the handle 830 can be differentthan shown in FIGS. 19A-19B and described herein.

With reference to FIGS. 20A and 20B, the clamp 840 can comprise anelongate member having a slight curve. A proximal portion of the clamp840 can include a handle or grasping portion 848 that a user can gripduring use of the device. A distal portion 846 of the clamp 840 isgenerally sized, shaped and otherwise configured such that it can bemoved within the slit 818 of the introducer tube 810. In someembodiments, as illustrated herein, the distal end of the clamp 840comprises a key 847 for insertion within the keyhole or other opening837 of the handle 830 in order to couple the clamp to the handle.

Therefore, the handle 830 and the clamp 840 can be connected to oneanother about a hinge or other rotatable point, thereby permitting thehandle to be selectively rotated and/or otherwise moved relative to theclamp. As discussed in greater detail herein, such a relative rotationbetween the clamp and the handle can be used to provide the mechanicalforce necessary to move the plunger 820 within the introducer tube 810.This can advantageously urge an implant (e.g., tapered hydrogel implant)through the tube 810 and into a target recess of an implant site.Accordingly, the forces created by moving the clamp relative to thehandle can help move an implant against relatively high back-forces(e.g., against relatively high friction and/or other resistive forces)within the introducer tube. Such movement of the implant can beparticularly difficult for reverse tapered implants where at least aportion of such implants experiences generally high radially compressiveforces while being moved through an interior lumen or other opening ofthe introducer tube 810.

According to some embodiments, to assemble the delivery device 800 inpreparation for use, the user inserts the implant 10 (e.g., reversetapered implant, other joint implant, etc.) into the introducer tube 810via the proximal end 802. The plunger 820 can then be inserted into theproximal end 802 of the introducer tube 810 and used to distally advancethe implant 10 within the introducer tube 810. Once the handle 830 iscoupled to the introducer tube 810 (e.g., by threading the nut portionor introducer tube receiving portion 834 onto the externally threadedportion 814 of the introducer tube 810), the clamp 840 can be coupled tothe handle 830 by inserting the key 847 (or other protruding portion orfeature) of the clamp 840 into the keyhole 837 (or other opening) of thehandle 830. When assembled, e.g., as illustrated in FIGS. 16A, 16C, 16Dand 21A-21C, the clamp 840 is generally positioned and movable withinthe slit 818 of the introducer tube 810.

As discussed in greater detail herein, the clamp 840 can be rotatablyattached to the handle 830 (e.g., at a hinge point), thereby allowing auser to selectively rotate or otherwise move the clamp relative to thehandle (e.g., to move the clamp 840 toward or away from the handle 830within the slit, groove or other opening of the introducer tube 810). Insome embodiments, an offset between the distal section 836 and proximalsection 832 of the handle 830 permits the distal portion 846 of theclamp 840 to be aligned with the slit 818 in the introducer tube so thatthe clamp can be selectively moved within the slit 818 when the clamp840 and handle 830 are coupled to one another (e.g., via the key847-keyhole 837 joint or a similar feature or mechanism). Therefore, insome embodiments, the delivery device 800 is configured for quick, easyand convenient assembly and disassembly for cleaning, sterilization,repair, maintenance and/or any other reason or purpose.

According to some embodiments, the various components of themechanically-assisted delivery device 800 comprise one or more rigidand/or semi-rigid materials that are configured to withstand the forces,moments, chemicals and/or other substances, temperature fluctuationsand/or other elements to which they may be exposed. For example, thecomponents of the implant delivery device can comprise one or moremetals (e.g., stainless steel, other surgical steel, other types ofsteel, etc.), alloys, plastics and/or the like. Such materials canpermit the device to be autoclaved, sterilized or otherwise cleanedduring a specific disinfection protocol. In addition, the structural andother physical characteristics of the device can permit the user toexert the necessary forces using the device to deliver implants ofvarious sizes, shapes and/or configurations through the correspondingintroducer tube and into a target implant site of a patient.

In use, the distal neck portion 806 of the introducer tube 810 can bepositioned at least partially within the opening, recess or otherimplant site into which the implant 10 will be secured. In someembodiments, the introducer tube 810 is sized, shaped and otherwiseconfigured to that the neck portion 806 fits generally snugly within theimplant site. To deliver the implant 10 (e.g., reverse taper implant)through the device 800 and into the targeted implant site, the user canurge the clamp 840 toward the handle 830 of the device (e.g., so thatthe clamp rotates or otherwise moves relative to the handle). Accordingto some embodiments, as the distal portion 846 of the clamp 840 movesdownwardly through the slit, slot or other opening 818 of the introducertube 810, a portion of the clamp 840 (e.g., the distal portion 846)contacts the plunger 820 (e.g., the domed proximal end 824), and urgesthe plunger 820 distally within the introducer tube 810.

As illustrated in FIGS. 21A-21C, such a movement, in turn, urges theimplant 10 distally within the introducer tube 810. As the implant 10 isurged deeper (e.g., more distally) into the interior of the introducertube 810, the implant 10 may become radially compressed by the interiorshape (e.g., tapered portion 816 a) of the introducer tube 810. Ifsufficient force is applied to the implant 10 by moving the clamprelative to the handle, the implant 10 can pass through the neck portion806 of the introducer tube and into the implant site. In someembodiments, the motion limiter 828 or similar feature of the plunger820 can contact the distal end of the slit or similar opening 818 of theintroducer tube 810 when the implant 10 has been released from thedelivery device 800 into the implant site. As depicted in FIG. 21C, thiscan help prevent the plunger 820 from continuing to move toward and intothe implant site and possibly damaging the implant site and/or theimplant 10. While the user grasps the handle 830 and the clamp 840 withone hand, he or she can apply a required force on the flange 819 thatextends outwardly from the proximal end 802 of the introducer tube 810with the other hand to stabilize and control the introducer 810.

Accordingly, the mechanically-assisted delivery devices disclosedherein, or equivalents thereof, can facilitate the compression anddelivery of reverse tapered implants within a target implant site. Insome embodiments, the mechanically-assisted delivery device can beconfigured to be operated at least partially with the assistance of amechanical motor, a pneumatic device and/or another external device. Forexample, the clamp of the device can be moved relative to the handle byor with the assistance of one or more motors (e.g., regulated by a userusing a button, knob, dial and/or other controller). Such embodimentscan further facilitate the delivery of implants within an implant siteof a patient.

To assist in the description of the disclosed embodiments, words such asupward, upper, bottom, downward, lower, rear, front, vertical,horizontal, upstream, downstream have been used above to describedifferent embodiments and/or the accompanying figures. It will beappreciated, however, that the different embodiments, whetherillustrated or not, can be located and oriented in a variety of desiredpositions.

Although several embodiments and examples are disclosed herein, thepresent application extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinventions and modifications and equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the inventions. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combine with or substituted for one another in orderto form varying modes of the disclosed inventions. Thus, it is intendedthat the scope of the present inventions herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

What is claimed is:
 1. A method of creating a wedge-shaped recess in abone, the method comprising: creating a cylindrical recess within abone, the cylindrical recess comprising cylindrically-shaped side wallsand a bottom surface, wherein the cylindrical recess comprises alongitudinal axis; positioning a tool within the cylindrical recess,wherein a distal end of the tool comprises a tapered end, the taperedend of the tool being sized and configured to be placed within thecylindrical recess; and radially expanding an articulating cutter of thetool and rotating the tool to remove additional bone along thecylindrical side walls and to create a wedge-shaped recess; wherein thearticulating cutter is expanded radially outwardly at an angle relativeto the longitudinal axis; and wherein, after the wedge-shaped recess isformed, a diameter of the bottom surface of the wedge-shaped recess islarger than a diameter of a surface opening of the wedge-shaped recess.2. The method of claim 1, wherein the tool is cannulated, and whereinthe tool is positioned over a guide pin to place a distal end of thetool near a targeted location of the recess.
 3. The method of claim 1,wherein a ratio of the diameter of the bottom surface to the diameterthe surface opening is between 1.05 and 1.3.
 4. The method of claim 1,wherein a ratio of the diameter of the bottom surface to the diameterthe surface opening is at least 1.1.
 5. The method of claim 1, whereinthe diameter of the bottom surface is 5% to 25% larger than the diameterthe surface opening.
 6. The method of claim 1, wherein the recess islocated within or near at least one of a toe, finger, ankle, knee,shoulder, hip or other joint.
 7. The method of claim 1, wherein thesurface opening is 5 mm to 20 mm in diameter.
 8. A method of creating awedge-shaped recess in a bone, the method comprising: creating acylindrical recess, the cylindrical recess comprisingcylindrically-shaped side walls and a bottom surface, wherein thecylindrical recess comprises a longitudinal axis; and creating awedge-shaped recess by removing additional bone from thecylindrically-shaped side walls; wherein creating the wedge-shapedrecess comprises actuating an articulating cutter of a tool and rotatingthe tool; wherein actuating an articulating cutter comprises radiallyexpanding the articulating cutter radially outwardly at an anglerelative to the longitudinal axis; and wherein, after the wedge-shapedrecess is formed, a diameter of the bottom surface of the wedge-shapedrecess is larger than a diameter of a surface opening of thewedge-shaped recess.
 9. The method of claim 8, wherein the tool iscannulated, and wherein the tool is positioned over a guide pin to placea distal end of the tool near a targeted location of the recess.
 10. Themethod of claim 8, wherein a ratio of the diameter of the bottom surfaceto the diameter the surface opening is between 1.05 and 1.3.
 11. Themethod of claim 8, wherein a ratio of the diameter of the bottom surfaceto the diameter the surface opening is at least 1.1.
 12. The method ofclaim 8, wherein the diameter of the bottom surface is 5% to 25% largerthan the diameter the surface opening.
 13. The method of claim 8,wherein the recess is located within or near at least one of a toe,finger, ankle, knee, shoulder, hip or other joint.
 14. The method ofclaim 8, wherein the surface opening is 5 mm to 20 mm in diameter.